Enzymatic Hemoglobin A1c assay for the Atellica CH AnalyzerDiagnosing and monitoring diabetes using the new HbA1c assay

Diabetes is a growing global problem. An estimated 463 million adults have diabetes mellitus,1 a chronic disease caused by inadequate production of, or cellular sensitivity to, insulin, resulting in abnormally high blood glucose (hyperglycemia). Glycemic states can be measured by fasting blood glucose, fructosamine, or glycated hemoglobin (HbA1c). Siemens Healthineers is proud to offer the Enzymatic Hemoglobin A1c assay for the Atellica CH Analyzer to meet the increasing demand for HbA1c testing. It was developed to measure HbA1c for the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and identification of those at risk for developing diabetes mellitus.

IDF Diabetes Atlas. Eighth edition 2017. http://www.diabetesatlas.org/

Features and Benefits:

  • Provides confidence in results with a NGSP certified and IFCC standardized A1c assay
  • Offers high precision and accuracy that meets new standards in A1c testing
  • Demonstrates < 5% change with most known HbA1c variants (HbC, HbD, HbE, HbS, and HbA2)


Assay Specifications

Enzymatic Hemoglobin A1c assay

Sample Type

whole blood and hemolysate

Sample Volume

4.5 µL

Detection Capability

LoB: 3.11 %HbA1c
LoD: 3.53 %HbA1c

Lot Calibration Interval

180 days

Pack Calibration Interval

63 days

Reagent Onboard Stability

63 days

Time to First Result

10 minutes

Measuring Interval

3.80–14.00 %HbA1c
(18.03–129.50 mmol/mol)